Treatment of Impulsive Aggression in Subjects With ADHD in Conjunction With Standard ADHD Treatment (CHIME 2)

PHASE3CompletedINTERVENTIONAL
Enrollment

297

Participants

Timeline

Start Date

February 16, 2016

Primary Completion Date

November 15, 2019

Study Completion Date

February 14, 2020

Conditions
Attention Deficit Hyperactivity Disorder (ADHD)
Interventions
DRUG

SPN-810 (18 mg)

Subjects were randomized to receive SPN-810 9 mg twice each day with food, in addition to the stable dose of the optimized ADHD medication determined from the lead-in period. If initiating treatment before noon, patients should start with the morning dose; if afternoon, the evening dose.

DRUG

SPN-810 (36 mg)

Subjects were randomized to receive SPN-810 18 mg twice each day with food, in addition to the stable dose of the optimized ADHD medication determined from the lead-in period. If initiating treatment before noon, patients should start with the morning dose; if afternoon, the evening dose.

DRUG

Placebo

Subjects were randomized to receive Placebo twice each day with food, in the morning and in the evening, in addition to the stable dose of the optimized ADHD medication determined from the lead-in period. If initiating treatment before noon, patients should start with the morning dose; if afternoon, the evening dose.

Trial Locations (32)

10029

Icahn School of Medicine at Mount Sinai, New York

20310

Children's National Medical Center/Children's Research Institute, Washington D.C.

30030

iResearch Atlanta, Decatur

30331

Atlanta Center for Medical Research, Atlanta

32803

APG Research, LLC, Orlando

33012

Indago Research & Health Center, Inc., Hialeah

33143

Miami Research Associates, South Miami

33319

Innovative Clinical Research, Inc, Lauderhill

33613

University of South Florida- Dept. of Psychiatry and Neurosciences, Tampa

33912

Gulfcoast Clinical Research Center, Fort Myers

42301

Pedia Research, Owensboro

45219

University of Cincinnati Department of Psychiatry and Behavioral Neuroscience, Cincinnati

47715

Pedia Research, Evansville

60563

AMR Conventions Research, Naperville

63304

St. Charles Psychiatric Associates Midwest Research Center, Saint Charles

68114

Quality Clinical Research, Omaha

68526

Alivation Research, LLC, Lincoln

71103

Laszlo J. Mate, M.D., P.A., North Palm Beach

Louisiana State University Health Sciences Center, Shreveport

72211

Woodland International Research Group, Little Rock

75115

InSite Clinical Research, DeSoto

78759

BioBehavioral Research of Austin P.C., Austin

80910

MCB Clinical Research Centers, LLC, Colorado Springs

83642

Advanced Clinical Research, Meridian

84015

Ericksen Research & Development, Clinton

85226

Metropolitan Neuro Behavioral Institute, Chandler

90807

Alliance for Wellness dba Alliance for Research, Long Beach

91402

ASCLEPES Research Center, Panorama City

92251

Sun Valley Research Center, Imperial

98011

Pacific Institute of Medical Sciences, Bothell

08009

Hassmann Research Institute, Berlin

Unknown

Houston Clinical Trials, Houston

All Listed Sponsors
lead

Supernus Pharmaceuticals, Inc.

INDUSTRY

NCT02618434 - Treatment of Impulsive Aggression in Subjects With ADHD in Conjunction With Standard ADHD Treatment (CHIME 2) | Biotech Hunter | Biotech Hunter